Beta-glucan from Euglena gracilis microalgae: authorised novel food in the EU

Conditions of use and maximum levels

Table 1, column "Conditions under which the novel food may be used", as written:

• Cereal bars: 670 mg/100 g
• Total diet replacement for weight control as defined in Regulation (EU) No 609/2013: 600 mg/day
• Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children: 100 mg/day for children from 3 to 9 years of age 150 mg/day for children from 10 to 17 years of age 200 mg/day for adults

Additional specific labelling requirements

For Cereal bars; Total diet replacement for weight control as defined in Regulation (EU) No 609/2013: The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘beta-glucan from Euglena gracilis microalgae’.

For Food supplements as defined in Directive 2002/46/EC, excluding food supplements for infants and young children: 1. The designation of the novel food on the labelling of the foodstuffs containing it shall be ‘beta-glucan from Euglena gracilis microalgae’. 2. The labelling of food supplements containing the novel food shall bear a statement that they should only be consumed by persons above 3 years of age/above 9 years of age/adults, depending on the age group the product is intended for

Specification (Table 2)

Table 2 of the Annex, row with the same name, as written:

Description/Definition:

The novel food, beta-glucan from Euglena gracilis microalgae (paramylon), is a linear, unbranched beta-1,3-D-glucan polymer derived from the non-GM microalga Euglena gracilis.

The novel food is produced by fermentation, followed by pH adjustment and homogenization to release the beta-glucan granules. The granules are isolated by decanting and washing, and subsequently, acidified and filtered. After drying, the product is milled. The process includes conditions such as an alkaline pH and heat-killing step of the microalga to ensure the absence of viable Euglena gracilis cells in the novel food.

Characteristics/composition:

Appearance: cream white powder

Beta-glucan (30): (%) ≥ 95

Moisture (%): ≤ 6

Ash (%): ≤ 1

Heavy metals:

Lead (mg/kg): ≤ 0,5

Cadmium (mg/kg): ≤ 0,5

Mercury (mg/kg): ≤ 0,05

Arsenic (mg/kg): ≤ 0,02

Microbiological criteria:

Total aerobic microbial count (CFU/g): ≤ 3 000

Total yeast and mould count (CFU/g): ≤ 100

Coliforms (MPN/g): ≤ 30

Escherichia coli: Not detected in 10 g

Staphylococcus aureus: Not detected in 10 g

Salmonella spp.: Not detected in 25 g

Listeria monocytogenes: Not detected in 25 g

CFU: colony forming units, MPN: most probable number.

Source and version

Implementing Regulation (EU) 2017/2470, Annex, Union list of novel foods, Table 1. Consolidated text of 10 August 2026. The text above is copied from that document without change except that amendment markers are removed. It is not advice and it does not decide whether a particular product is covered.

• Consolidated text on EUR-Lex

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